Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Summary

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Timeline

Start

2011-07

Primary completion

2013-10

Completion

2013-10

Outcome

Met primary endpoint

paper The primary efficacy endpoint was reached by 33.5% of subjects taking febuxostat 80 mg/day PMID 26013187 ↗

paper P < 0.001 for the comparison between febuxostat 80 mg/day and allopurinol 300 mg/day groups PMID 26013187 ↗

Publications

• Xu S, Liu X, Ming J, Chen S, Wang Y, Liu X, Liu H, Peng Y, Wang J, Lin J, Ji H, Liu B, Lu Y, Liu P, Zhang Y, Ji Q. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis. 2015 Jul;18(6):669-78. doi: 10.1111/1756-185X.12648. Epub 2015 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Allopurinol	Small molecule	100 mg	Oral
Subject	Febuxostat	Small molecule	40 mg	Oral
Subject	Febuxostat	Small molecule	80 mg	Oral

Indications